BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEON PTCA BALLOON DILATATION CATHETER

    MDR report key: 15280600 · Received August 24, 2022

    Report

    Report Number
    3002808904-2022-00009
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 2, 2022
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "NEON", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "RX TAKERU PTCA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K163372. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE SHAFT-PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: THE DISTAL END OF THE INNER SHAFT (GW LUMEN) WAS ELONGATED AND SPRIT. APPROXIMATELY 4MM OF THE PROXIMAL PART OF BALLOON WAS LEFT, AND THE DISTAL PART WAS NOT RETURNED. THE FRACTURED PART WAS SPRIT IN HORIZONTALLY. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO BREAKAGE OF THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, WHILE WITHDRAWAL OF THE CATHETER SHAFT, THE DISTAL TIP WAS STUCK AT THE LESIONS, AND THEN BROKEN DUE TO EXCESSIVE PULLING FORCE WAS LOADED, WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. WE SPECULATED THAT APPROXIMATELY 3MM OF DISTAL TIP AND 11MM OF BALLOON WAS LEFT IN PATIENT BODY. IN THE INSTRUCTIONS FOR USE OF NEON (3229-3) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW: [PRECAUTIONS DURING USAGE] [IMPORTANT BASIC PRECAUTIONS] THIS CATHETER MAY BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). SINCE SERIOUS COMPLICATIONS MIGHT ARISE WHEN USING THIS CATHETER, OPERATION SHOULD BE DONE IN THE MEDICAL INSTITUTION WHERE EMERGENCY PROCEDURE CAN BE EXECUTED. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. IF ABNORMAL OR STRONG RESISTANCE IS EXPERIENCED DURING THE OPERATION, THE CAUSE FOR SUCH ABNORMALITY OR RESISTANCE SHOULD BE VERIFIED AND APPROPRIATE MEASURES SHOULD BE PERFORMED BEFORE PROCEEDING. (IF SUCH ABNORMALITY OR RESISTANCE IS IGNORED AND EXCESSIVE FORCE IS APPLIED, IT MAY LEAD TO DAMAGE OF THE VESSELS OR TO THE CATHETER SHAFT BREAKING AND REMAINING INSIDE THE BODY). [ADVERSE EVENTS] ADVERSE EVENTS RELATED TO THE PRODUCT INCLUDE, BUT ARE NOT LIMITED TO, INFARCTION CAUSED BY OCCLUSION OF DISTAL VESSELS OR SIDE BRANCH, VASOSPASM, STRIPPING OF VASCULAR ENDOTHELIUM, DISSECTION OF VASCULAR INTIMA, RE-OCCLUSION, VASCULAR PERFORATION OR RUPTURE, UNSTABLE ANGINA, BLOOD PRESSURE FLUCTUATION, STROKE, SHOCK, REACTION TO DRUGS, REACTION TO CONTRAST MEDIA, RENAL INSUFFICIENCY, TRANSIENT ISCHEMIA, AIR EMBOLISM, THROMBOEMBOLISM, INTERNAL BLEEDING, HEMATOMA, INFECTION, ETC. THESE ADVERSE EVENTS MAY CAUSE EMERGENT CORONARY BYPASS SURGERY, MYOCARDIAL INFARCTION, RE-STENOSIS, CARDIAC TAMPONADE, HEMORRHAGE, EMERGENT BRAIN SURGERY FOR CEREBRAL INFARCTION, FORMATION OF VESSEL FISTULA, ANEURYSM, ARRHYTHMIA, AND EVEN DEATH.

    Description of Event or Problem · 0

    AT 10 ATM, RUPTURE OF THE BALLOON CATHETER OCCURRED. THE PHYSICIAN TRIED COMPLETELY RETRIEVING THE BROKEN DISTAL PART BY USING THE SNARING TECHNIQUE, BUT SOME PIECES OF THE BALLOON WERE LEFT IN THE PATIENT'S BODY. TO BAIL OUT, ONE BARE METAL STENT WAS DEPLOYED. AFTER THE PROCEDURE, PROPER STENT EXPANSION AND NO RESIDUAL DISSECTION FLAP WERE DETECTED EITHER BY IVUS OR CAG. THE FINAL CAG SHOWED A GOOD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435584 NEON PTCA BALLOON DILATATION CATHETER NEON LOX KANEKA CORPORATION SR121521

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other